Keywords: Regulatory science, medical device design, content design, user experience design
Client: © RegMetrics Pvt. Ltd.
Funded by: RegMetrics Pvt. Ltd.
Role: Content design (consultant)
Co-designed with: Natural Interactions Lab, University of Oxford
Product website: https://www.reg-metrics.com/
Navigating the medical device regulations can be a complex challenge, particularly for those with no prior experience. Most entrepreneurial ventures hire consultants for this process, but these can be exorbitantly expensive. Furthermore, the process of developing a medical device is in itself lengthy, capital intensive and laced with risks at every step. Knowing whether a concept can be deemed a medical device and how it could be classified can substantially change the pathway to commercialisation and the associated resources required. The lack of an understanding of regulatory frameworks can create a major barrier to entry for most start ups and innovators in this field.
RegMetrics is an AI-based digital product that can help companies navigate the medical device regulations for a fraction of the cost of traditional consultancy services. First developed at the University of Oxford, the product can assist with categorising the proposed concept or product within the medical device classification, generate a pathway for risk assessment, quality management and commercialisation and identify the relevant standards and test houses to proceed with product benchmarking and risk assessment.
My role in this project was the development of content for the General Safety and Performance requirements for medical devices and in-vitro devices as per the EU Medical Device Regulations. In 2024, the product transitioned to a paid service and has more than 2300 users.